Cardiovascular safety; Obesity – Glucagon; Semaglutide; Type 2 diabetes; 1; Oral administration; like peptide; Glucagon-Like Peptide-1 Receptor; Hypoglycemic Agents; semaglutide; Glucagon-Like Peptides; Humans; Diabetes Mellitus, Type 2/drug therapy
Abstract :
[en] Oral semaglutide (Rybelsus®) is a co-formulation of semaglutide, a glucagon-like peptide-1 (GLP-1 RA) receptor agonist, with an absorption enhancer, sodium N- (8- [2- hydroxybenzoyl] amino) caprylate (SNAC), which facilitates the absorption of semaglutide across the gastric epithelium in a concentration dependent manner. The safety and efficacy of oral semaglutide were assessed in the PIONEER clinical trial programme, which included 9543 patients with type 2 diabetes (T2DM). Across a range of different T2DM patients receiving different background medications, oral semaglutide provides more effective glycaemic control than common oral glucose-lowering therapies, associated with a clinically relevant reduction in body weight, including in patients with more advanced T2DM on insulin treatment. The tolerability profile for oral semaglutide was consistent with the other GLP-1 RAs. Cardiovascular (CV) safety of oral semaglutide was noninferior to placebo in CV high-risk patients. Available in three doses (3, 7 and 14 mg) to be gradually increased, Rybelsus® is currently reimbursed in Belgium after failure of antidiabetic treatment (including metformin; HbA1C superior to 7.5 % or 58 mmol/mol) in T2DM patients with a body mass index ? 30 kg/m². [fr] Le sémaglutide oral (Rybelsus®) est une co-formulation du sémaglutide, agoniste des récepteurs du glucagon-like peptide-1 (AR GLP-1), couplé à un rehausseur d’absorption, le sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC), ce qui facilite le passage du sémaglutide au travers de l’épithélium gastrique de manière dose-dépendante. La sécurité et l’efficacité du sémaglutide oral (SO) ont été évaluées dans le programme d’études cliniques PIONEER, qui a inclus 9.543 patients diabétiques de type 2 (DT2). Dans une large gamme de patients DT2 ayant bénéficié de différents médicaments hypoglycémiants préalables, le SO permet d’obtenir un contrôle glycémique plus efficace qu’avec les traitements hypoglycémiants oraux courants, ainsi qu’une perte de poids intéressante, y compris chez les patients atteints de DT2 plus avancé traités par insuline. Le profil de tolérance du SO est comparable aux autres AR GLP-1 et la sécurité cardiovasculaire établie chez des patients à haut risque par rapport au placebo (non-infériorité). Disponible en trois posologies (3, 7 et 14 mg) à accroître progressivement, Rybelsus® est remboursé en Belgique après échec d’un traitement antidiabétique (dont la metformine; HbA1C sup�rieur a 7,5 % ou 58 mmol/mol) chez des patients DT2 avec un indice de masse corporelle ? 30 kg/m².
Disciplines :
Endocrinology, metabolism & nutrition
Author, co-author :
Paquot, Nicolas ; Centre Hospitalier Universitaire de Liège - CHU > > Service de diabétologie, nutrition, maladies métaboliques
Language :
French
Title :
Le médicament du mois. Le sémaglutide oral, premier agoniste des récepteurs du GLP-1 administré par voie orale (Rybelsus®).
Alternative titles :
[en] Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®).
Publication date :
December 2021
Journal title :
Revue Médicale de Liège
ISSN :
0370-629X
eISSN :
2566-1566
Publisher :
Université de Liège. Revue Médicale de Liège, Liège, Be
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